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news.Ruthigen has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for clinical trial of RUT58-60, a new chemical formulation containing hypochlorous acid (HOCl) with no hypochlorite that utilizes other small molecule stabilizers such as magnesium.
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Ruthigen plans to begin its combined Phase I/II clinical trial for its lead drug candidate RUT58-60 as early as July 2014. The study may be conducted at up to 20 clinical.
The Phase I/II clinical trial will be a double blind, randomized controlled study designed to evaluate the safety and efficacy of RUT58-60 Lavage following abdominal surgery as an adjunctive therapy to prophylactic systemic antibiotics.
University of Cincinnati’s College of Medicine professor of surgery and colorectal surgeon Dr Janice Rafferty will be the principal investigator of the Phase I/II clinical trial.
According to Ruthigen, the company has incorporated FDA’s feedback, received in connection with the company’s previously conducted pre-IND meeting, into the development program.
The Phase I/II trial design contemplates an initial enrollment of approximately 20 patients as part of a brief Phase I component of the study to establish the safety and tolerability of RUT58-60 in humans. The study will remain blinded with the exception of the safety portion for the initial 20 patients.
Subject to confirmation by the data monitoring committee of no significant adverse events, the company plans to continue the enrollment of the remaining 130 patients in the clinical trial.
Ruthigen chairman, CEO and Chief Scientific Officer Hoji Alimi noted the company expects to complete its combined Phase 1/2 trial by early 2015 and enter into its first pivotal trial, pending FDA review, shortly thereafter.
"The combined Phase 1/2 trial is designed as an exploratory trial to evaluate the potential safety and efficacy of RUT58-60 as a prophylactic drug for use in abdominal surgery.
"We will also evaluate the potential of our lead drug candidate against the following parameters: 1) infection rates, 2) patient discharge times, and 3) number of patients returning to the hospital due to post-surgical infection.
"These three parameters will be evaluated on day 0, at hospital discharge or day 7, day 14 and day 28 post surgery. Based on the data we collect, we expect to gain meaningful insights to inform the design of the clinical endpoints for our pivotal trials," Alimi added.
Ruthigen has designed RUT58-60, a broad-spectrum anti-infective drug candidate, for prophylactic use during invasive surgical procedures. The company’s lead drug candidate has been shown in laboratory tests to eradicate both gram-positive and gram-negative bacteria, including antibiotic resistant bacteria within the first 30 seconds of contact, according to Ruthigen.
Ruthigen claims that RUT58-60 improves patient lives, re-defines infection control in surgical procedures and delivers cost savings to hospitals.
Image: Ball and stick model of the hypochlorous acid molecule. Photo: Courtesy of Jynto.